Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT00879658
Eligibility Criteria:
Key inclusion Criteria:
* Diagnosis of Multiple Sclerosis (MS) as defined by revised McDonald criteria.
* A relapsing-remitting course of disease with at least 1 documented relapse during the previous year, or 2 documented relapses during the previous 2 years, or a positive gadolinium (Gd)-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a second scan may be obtained 1 month later.)
* An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization.
* Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization.
* Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.
Key exclusion Criteria:
* A manifestation of another type of MS than RRMS
* History of chronic disease of the immune system other than MS
* Malignancies, diabetes, significant cardiovascular, pulmonary and hepatic diseases and conditions
* Active infections
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00879658
Study Brief:
Protocol Section:
NCT00879658